Active Ingredient
Zinc Oxide(40%)
Diaper Rash Cream 15oz Cream
FDA Label NDC 57337-169
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rejoice International Corp. for the product Diaper Rash Cream 15oz (NDC 57337-169). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Protectant
Use
- helps treat and prevent diaper rash
- protects chafed skin due to diaper rash and helps seal out wetness
Warnings
For external use only
When Using This Product
When using this product do not get into eyes.
Stop Use And Ask A Doctor If
- condition worsens
- symptoms last more than 7 days or clear up and occur again with a few days.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- change wet and soiled diapers promptly
- cleanse the diaper area
- allow to dry
- apply cream liberally as often as necessary, with each diaper change especially at bedtime or anytime when exposure to wet diapers will be prlonged
Other Information
- store at 68° to 77° F (20° to 25°C)
- do not use if tube seal under cap is broken or missing
Inactive Ingredients
Petrolatum
Mineral Oil
Lanolin
Isopropyl Myristate
Beeswax
Tocopheryl Acetate
Cod Liver Oil
Aloe Barbadensis Leaf Juice
Label
Label (Label 07721)
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